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Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03621384
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Pringgodigdo Nugroho, MD, Indonesia University

Brief Summary:

Background: Diabetic kidney disease (DKD), as one of chronic complication of type 2 diabetes mellitus, is common cause of end stage renal disease (ESRD). Vitamin D deficiency is known as one of DKD risk factors. Recent studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be due to vitamin D receptor gene polymorphisms, which is affected by BsmI, Cdx2, ApaI, FokI, and TaqI gene. The investigators conducted cross-sectional study to investigate association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease

Hypothesis: BsmI polymorphisms in vitamin D receptor gene is associated with diabetic kidney disease (DKD)


Condition or disease
Diabetic Kidney Disease

Detailed Description:

Diabetic kidney disease (DKD) is a common cause of end stage renal disease (ESRD). Data from Indonesian Renal Registry (2011) revealed that 25% etiology of patients who underwent hemodialysis is DKD. Risk factors that are associated with DKD include blood glucose control, hypertension, dyslipidemia, duration of diabetes mellitus, high body mass index (BMI), age, sex, ethnicity, vitamin D deficiency, high sodium diet, high protein diet, and smoking.

The roles of vitamin D that are related to kidney are inhibition of renin transcription process, angiotensin II, renal inflammation process, and albumin excretion, prevention of podocytes damage, glomerulosclerosis process, and transformation from kidney epithelial cell into mesenchymal cell. Current studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be related to genetic factor which is vitamin D receptor polymorphisms. The vitamin D receptor polymorphism is affected by Cdx2, ApaI, BsmI, FokI, and TaqI gene, where Asian population is mostly affected by ApaI, FokI, and Cdx2.

Several studies had reported the association between BsmI polymorphisms in vitamin D receptor gene and DKD in various population. Zhang, et al (2012) study revealed the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Han Chinese population, while study from Vedralova, et al (2012) in Caucasian race showed opposite result. However, the association between BsmI polymorphism in vitamin D receptor gene and DKD has not been investigated in Indonesian-Malay race.

This is a cross-sectional study that investigate the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Indonesian-Malay race. The investigators collected data about study participants' characteristics, conducted physical examination and laboratory examination, which include BsmI polymorphisms in vitamin D receptor gene.


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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease
Actual Study Start Date : November 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
Bb Genotype
Subjects with Bb genotype of BsmI polymorphisms in vitamin D receptor gene
bb Genotype
Subjects with bb genotype of BsmI polymorphisms in vitamin D receptor gene



Primary Outcome Measures :
  1. Association between BsmI Polymorphisms in Vitamin D Receptor Gene and Diabetic Kidney Disease [ Time Frame: 1 month ]
    This study investigated association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease


Biospecimen Retention:   Samples With DNA
Urea, creatinine, estimated glomerular filtration rate (eGFR), fasting blood glucose (FBG), 2-hours postprandial blood glucose, HbA1c, total cholesterol, triglyceride, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, BsmI polymorphisms in vitamin D receptor gene


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Target population: type 2 diabetes mellitus patients who live in Indonesia

Accessible population: type 2 diabetes mellitus patients who visit internal medicine outpatient clinic of dr. Cipto Mangunkusumo Hospital

Sample: accessible population which meet study criteria

Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus patient
  • Indonesian-Malay race
  • Had signed the informed consent

Exclusion Criteria:

  • Urinary tract infection
  • Pregnant patient
  • Fever
  • In menstrual period
  • Had undergone hemodialysis or peritoneal dialysis
  • Had used non steroid antiinflammatory drugs (NSAIDs)
  • Postexercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621384


Locations
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Indonesia
dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Pringgodigdo Nugroho, MD Indonesia University
Principal Investigator: Suhardjono, Prof., MD, PhD Indonesia University
Principal Investigator: Aida Lydia, MD, PhD Indonesia University
Principal Investigator: Kuntjoro Harimurti, MD, PhD Indonesia University
Principal Investigator: Dekta Filantropi Esa, MD Indonesia University

Publications of Results:
Perhimpunan Nefrologi Indonesia. Report of Indonesian Renal Registry. Jakarta; 2011.
Abbasi MA, Abro A, Sheikh M. Smoking is related to albumin excretion in type 2 diabetes mellitus. Pak J Physiol. 2006;2(2):45-8.
Dewi K. Penurunan fungsi ginjal pada pasien DM tipe 2 di Poliklinik Endokrin Metabolik RSUPN Cipto Mangunkusumo. University of Indonesia; 2007.
Indra T. Asosiasi antara status vitamin D (25(OH)D) dengan albuminuria pada pasien diabetes melitus tipe 2. University of Indonesia; 2013.
Inassi J, Vijayalakshmy R. Role of duration of diabetes in the development of nephropathy in type 2 diabetic patients. Natl J Med Res. 2013;3(1):8-11.

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Responsible Party: Pringgodigdo Nugroho, MD, Head of Dialysis Unit, Dr Cipto Mangunkusumo General Hospital, Indonesia University
ClinicalTrials.gov Identifier: NCT03621384     History of Changes
Other Study ID Numbers: 756/UN2.F1/ETIK/2014
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pringgodigdo Nugroho, MD, Indonesia University:
BsmI
Diabetic kidney disease
Polymorphisms
Vitamin D receptor gene

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents